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A Senate bill that aims to raise the FDA's fiscal 2013 budget to $2.5 billion has gained support from the Alliance for a Stronger FDA, which calls it "strongly favorable" to the agency. The measure, which includes the new user fees for medical devices, drugs and biologics, provides $10 million to allow the FDA to beef up its inspections in China, the agency said.

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The FDA has issued a notice asking for feedback on its proposal to collect data in line with the record-keeping measures provided under the current good manufacturing practice quality system rules for medical devices. The agency will accept comments on the proposal through Sept. 30.

Drug-development groups and drugmakers are in disagreement over intellectual property provisions in the Trans-Pacific Partnership negotiations. An open letter was issued last week by the international charity Doctors Without Borders expressing major concern about the TPP's potential to curb access to drugs. PhRMA wants to use TPP talks to raise IP standards to U.S. levels, arguing that IP protections won't block access but provide an incentive for investments. "Strong intellectual property protections in the TPP to bolster biopharmaceutical innovation will help ensure that unmet patient needs are addressed," PhRMA said.

Indian authorities are investigating more than 12 pharmaceutical firms suspected of illegally exporting pseudoephedrine to Myanmar and China. At least one of the suspects owns drug manufacturing plants in India.

The FDA has appointed Dr. Kathleen Uhl as acting director of the Office of Generic Drugs. "Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position," Center for Drug Evaluation and Research Director Dr. Janet Woodcock wrote in a memo. Uhl previously was senior adviser to Dr. Greg Geba, who stepped down last week.

A group of 55 health care providers sent a letter to the FDA, requesting the agency not authorize the use of Gilead Sciences' Truvada for HIV prevention. The providers "strongly support continued research on the prevention of HIV, but oppose approval of
a pre-exposure prophylaxis that runs the risk of contributing to the spread of HIV and drug-resistant viruses," according to the letter.